Accreditation is the formal recognition, authorization, and registration of a laboratory that has shown that it has the capacity and reliability to perform the functions claims to be able to perform. It provides feedback to laboratories on whether they are performing their duties in accordance with international standards of technical expertise. Laboratory accreditation is a way to improve customer confidence in laboratory reports released so that doctors and patients can receive reports with confidence. The National Accreditation Board for Testing and Calibration Laboratories (NABL) is an independent body under the Department of Science and Technology, under the Government of India, and is registered under the Societies Act. NABL, which was originally established for the purpose of accrediting testing and evaluation laboratories, later expanded its services to clinical laboratories in our country.


  • In December 2019, a novel coronavirus (COVID -19) was used with an outbreak in Wuhan, China, and soon spread to another part of the world. It is believed that COVID-19 was delivered through the respiratory tract and can induce pneumonia.

  • The ongoing outbreak poses a challenge for public health laboratories is the outbreak is widespread and international spread through travelers is now clear aso spread sring.

  • Preferred testing /testing was performed by a molecular diagnosis of COVID-19 with real-time RT-PCR based on oral swarb, the time at which the disease was used by PHE laboratories.

  • PHE has been working closely with NHS England and Improvement ( NHS E and I) pathology Network Laboratories to increase the capacity of the test, which is now needed to continue to identify and maintain the required containment of affected individual and delay and maintain the required containment of affected individual and delay and mitigation of spread.

  • As part of the escalation and management of this viral infectious outbreak, a Phased approach to onboarding  NHS and me pathology Network Laboratories, across England, made undertaken, working closely with PHE, so that patients and NHS E and I staff can receive tests timely, internal intervention and treatment.


It is very important for a laboratory to make a definite plan for obtaining accreditation and nominate a responsible person as QUALITY MANAGER ( who should be familiar with the laboratory's existing quality system ) to coordinate all activities related to seeking accreditation. The laboratory should be carry-out the following important towards getting ready for accreditation:

1. Contact NABL Secretariat with a request for procuring relevant NABL documents ( NABL Contact address and the list of NABL documents given in Annexure-3 and 1, respectively ).

2. Get fully acquainted with all relevant documents and understand the assessment procedure and methodology of making an application.

3. Train a person on Quality Management System and Internal Audit ( 4-Day residential training courses conducted by NABL. Contact NABL Secretariat for details ).

4. Prepare QUALITY MANUAL as per ISO 15189 standards.

5. Prepare Standard Operating Procedure for each investigation carried out in the laboratory.

6. Ensure effective environmental conditions ( temperature, humidity, storage placement, etc ).

7. Ensure calibration of instruments/equipment. Only NABL ACCREDITED CALIBRATION LABORATORIES are authorized to provide calibration. NABL website gives the names of NABL accredited calibration laboratories in the various field of Accreditation.

8. Impact training on the key elements of documentation, such as document format, authorization of documentation of document, issue, and withdrawal procedures, document review and change, etc. Each document should have No., name of controlling authority, period of retention, etc.

9. Assassin the status of the quality system and technical competence with regard to NABL.

10. Remember that the Quality Manual is a policy document, in which they will be provided with support for other stages of the next level. We, therefore, ensure that these well-constructed books are well made.

11. Make sure the proper implementation of aspects is not found to have been written in Quality Manual and in other documents.

12. Incorporate Internal Quality ( IQC ) practice while patients samples are pointed upwards.

13. Documents IQS data is at the highest level undeniable. Maintain Levy Jennings Charts.

14. Participate in External Quality Assessment Schemes ( EQAS ). If this is not am available for certain analytes, participate in inter-laboratory comparison through the exchange of samples and NABL accredited laboratories.

15. Document corrective actions on IQC/EQA outliers.

16. Conduct Internal Audit and Update Management.

17. Apply to NABL along with appropriate money.

If you have any queries regarding NABL approval, eStartIndia will help you without any hassle.


An Accreditation laboratory is expected to submit to NABL5 copies of the application and 5 copies of the Quality Manual.

  • Quality Manual will be constructed by NABL to Lead Assessor to judge the adequacy of the quality Manual as to whether it is in compliance with ISO 15189 standards. After that when Lead Assessor will be able to do a Pre-Assessment of the laboratory for one day. Based on the Pre-Assessment report the laboratory may have to take certain corrective actions, so as to be fully prepared for the final assessment.

  •  It is essential for as well applicant accredited laboratories to satisfactorily participated in proficiency check/ Interlaboratorycomparisons / External quality assessment program as Asia Pacific LaboratoryAccreditation cooperation (APLAC) MutualRecognition Arrangement calls for mandatory participation in such programs. Each time the work is resumed, LeadAssessor will also be considered when it will be held for the last time. The number of technical assessors will subtract the value from the ofteishiclines applied for the number. I accreditation process involves a thorough assessment of all the elements of the laboratory that contribute to the production of accurate and reliable test data. These elements include staffing, training, supervision, quality control, equipment, recording and reporting of and test results environment which operates laboratory. The laboratory may take certain corrective actions, after the end of the term.

  •  After satisfactory corrective actions are taken by By the laboratory (a period of 3 months), the accreditation committee with examine the report and if recommended satisfied accreditation. The time required for the process of accreditation will depend upon the preparedness of the laboratory and its response to non- Conformances were suggested during the test and termination. Total duration ranges between 6 and 8 months.


Accreditation to a laboratory will be allowed to exist for up to three years. NABL will look at a variety of laboratories. Laboratories are improved compared to the scope of accreditation during observation. Laboratories require renewal of accreditation, and six months is very close to obtaining the expertise of the result of a re-examination.

eStartIndia is one of India’s Leading platforms helping for getting approval of NABL and any other medical and pharmaceutical license required for your business.


Damini Nagar
B.A LLB from Indore institution of Law

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